Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Prospective, Open-Label, Single-Center, Non-Comparative Study to Assess the Use of Pixel CO2 Laser System (FemiLift) in the Treatment of Vulvovaginal Atrophy (VVA) in Postmenopausal Female Subjects

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02747641
Recruitment Status : Completed
First Posted : April 22, 2016
Last Update Posted : November 21, 2017
Sponsor:
Collaborator:
The Cleveland Clinic
Information provided by (Responsible Party):
Alma Lasers Inc.

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
The purpose of this study is to assess the use of the Alma CO2 Pixel FemiLift™ in the treatment of VulvoVaginal Atrophy (VVA) in postmenopausal female subjects. The primary endpoint is to assess the change in the vaginal dryness by means of a Visual Analogic Scale (10 cm VAS) and/or Bachmann Index in VVA. The clinical improvement will be assessed by patient filled Vulvovaginal Atrophy.

Condition or disease Intervention/treatment Phase
Atrophy Vaginal Atrophy Genital Diseases, Female Procedure: Pixel CO2 Laser System Not Applicable

Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 15 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Prospective, Open-Label, Single-Center, Non-Comparative Study to Assess the Use of Pixel CO2 Laser System (FemiLift) in the Treatment of Vulvovaginal Atrophy (VVA) in Postmenopausal Female Subjects
Actual Study Start Date : May 2016
Actual Primary Completion Date : December 2016
Actual Study Completion Date : August 2017

Resource links provided by the National Library of Medicine


Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
treatment
only one arm
 Procedure: Pixel CO2 Laser System
Other Name: FemiLift


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Vulvovaginal Atrophy (VVA) [ Time Frame: 6 months ]
    Utilizing Bachman Vaginal Health Index


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   35 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy, non-smoking
  • Woman, age 35 to 70 yrs, menopausal
  • Provided written Informed Consent
  • Exhibiting VVA and/or SUI symptoms (mild or moderate SUI, according to severity index developed by Sandvik.)
  • Prolapse staged < II, according to the pelvic organ prolapse quantification (ICS-POP-Q) system
  • Normal PAP smear (up to 1 year prior to baseline)
  • Vaginal canal, introitus and vestibule free of injuries and bleeding
  • Have not had procedures in the anatomical area through 6 months prior to treatment
  • Understand and accept the obligation and is logistically able to present for all scheduled follow-up visits

Exclusion Criteria:

  • Severe prolapse (POP>= grade 3)
  • Use of photosensitive drugs
  • Acute or recurrent urinary tract infection (UTI), or genital infection (e.g. herpes candida).
  • Any serious disease, or chronic condition, that could interfere with the study compliance
  • Acute or actively present within the last 2 months HPV/HSV
  • Undiagnosed vaginal bleeding
  • Urge or overflow incontinence
  • Patients who are on antidepressants, or α-adrenergic and anticholinergic medications
  • Patients with immune system diseases.
  • Patients with allergic reaction to laser.
  • Obese women (BMI >30)
  • Patient unable to follow post-treatment instructions
  • History of keloid formation
  • Received or is anticipated to receive antiplatelets, anticoagulants, thrombolytics, vitamin E or anti inflammatories within 2 weeks pre treatment
  • A history of thrombophlebitis
  • A history of acute infections
  • A history of heart failure
  • Previously undergone reconstructive pelvic surgery
  • Have used vaginal creams, moisturizers, lubricants or homeopathic preparations for at least 3 months
  • Any medical condition that in the investigators opinion would interfere with the patients participation in the study
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02747641


Locations
Layout table for location information
United States, Florida
The Cleveland Clinic
Weston, Florida, United States, 33331
Sponsors and Collaborators
Alma Lasers Inc.
The Cleveland Clinic
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: Alma Lasers Inc.
ClinicalTrials.gov Identifier: NCT02747641    
Other Study ID Numbers: FLA 15-110
First Posted: April 22, 2016    Key Record Dates
Last Update Posted: November 21, 2017
Last Verified: October 2016
Additional relevant MeSH terms:
Layout table for MeSH terms
Atrophy
Pathological Conditions, Anatomical